Recruiting

Observational Study

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT05805410

Conditions

Child Behavior

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Not accepted

Interventions

robotic hippotherapy

Conventional physical therapy

Study Details

Brief summary:

Determine the effect of repeated pelvis perturbation training on trunk posture and locomotor function in children with CP.

Conditions

Child Behavior

Study ID

NCT05805410

Start date

Nov 1, 2022

Status verified date

May, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 4 - 12

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children with a diagnosis of bilateral spastic CP attributed to complications of prematurity, intracranial hemorrhage and periventricular leukmalacia according to the definition of Bax.
  • Children aged 4 to 12 years old without Botulinum toxin treatment within 6 months, and without surgeries (such as selective dorsal rhizotomy) within 12 months before the onset of the training.
  • Subjects will be able to remain seated without help for ≥10s.
  • GMFCS levels will be I to IV.
  • Children must be able to signal pain, fear or discomfort reliably.
  • Children with mild scoliosis (Cobb angle < 20 °).
  • Children with CP who have no prior hippotherapy experiences within 6 months.

Exclusion Criteria:

  • severe lower extremity contractures, fractures, osseous instabilities, osteoporosis.
  • severe disproportional bone growth.
  • unhealed skin lesions in the lower extremities.
  • thromboembolic diseases, cardiovascular instability.
  • aggressive or self-harming behaviors.

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Robotic hippotherapy

For the robotic training group, each subject will be trained for 40 minutes. Specifically, each participant will sit astride on a robotic horse with the force perturbation will be applied in the anterior-posterior direction and up/down direction.

active comparator: Conventional physical therapy

For the conventional physical therapy group, each subject will be trained for 40 minutes, which will include 10 minutes of stretching, followed by 10 minutes of sitting and 10 minutes of standing balance training, and 10 minutes of treadmill walking.

Interventions

robotic hippotherapy

A custom designed cable-driven robotic system that mimics horseback movement during walking was used in this study.

Conventional physical therapy

Stretching of trunk and leg muscles, followed by sitting and standing balance training, and conventional treadmill walking.

Primary outcome measure

  • Change in Trunk Control Measurement Scale (TCMS) score from baseline. [ Time Frame: baseline, post 6 weeks of training and 8 weeks after the end of training. ]

Central Contacts and Locations

Central contacts

Ming Wu

3122380700w-ming@northwestern.edu

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Ming Wu, PhD

3122380700mwu@ric.org

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

Jun 3, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2025-06-03.